The following data is part of a premarket notification filed by Biopool International, Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK980035 |
| 510k Number | BK980035 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Biopool International, Inc. 1230 Wilson Drive West Chester, PA 19380 US |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-06 |
| Decision Date | 1999-06-11 |